Articles Posted inDrug Companies

Xarelto is a new-generation blood thinner that was initially approved by the U.S. Food & Drug Administration in October 2011. Xarelto is intended to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation, to treat deep vein thrombosis (DVT) and pulmonary embolism (PE). The drug is also to reduce the risk of recurrence of DVT or PE, and for prophylaxis of DVT for patients undergoing hip and knee replacement surgery.

This drug has made Bayer and Johnson & Johnson a fortune. It has also left them as the defendants in 21,400 Xarelto bleeding lawsuits from patients or surviving families allege they have suffered gastrointestinal and cerebral hemorrhages, hemorrhagic strokes and other types of bleeding issues that have caused injury or death. Xarelto carries a significant risk of severe, and sometimes even fatal, internal bleeding – and there is no reversal agent available if serious bleeding occurs with Xarelto use.

Nexium is a controversial drug. At one point, bone fracture lawsuits were all the rage because there was data suggesting Nexium, particularly the long-term use of Nexium, would cause bone fractures and breaks. We believed many of these cases were meritorious. But the litigation did not get very far.

Five plaintiffs last week sought an MDL for federal lawsuits against Pfizer’s Lipitor. The allegations are the same in all cases: the cholesterol drug caused them to develop diabetes.

The gist of plaintiffs claims is that the drug increased serum glucose levels causing diabetes. Pfizer never properly let patients or doctors know of this risk so they could make a different choice or perhaps avoid this class of drugs all together. Accordingly, the suits allege, Lipitor is defective and unreasonably dangerous and the drug was sold with a warning that did not properly alert patients and doctors of the risk.

Not for nothing, Pfizer has been making money had over fist with Pfizer. If you have help Pfizer stock in the last few years, you have gotten pretty rich in no small part due to Lipitor.

Almost all prescription drugs carry the potential for side effects. Some of these are minor, others significant. Recent data suggests that Lipitor, the popular cholesterol drug, is strongly correlated with increased rates of Type 2 diabetes.

Lipitor (atorvastatin calcium), made by Pfizer, is a statin. Statins reduce cholesterol by blocking specific liver enzymes. By blocking these cholesterol-producing enzymes, the body begins to use cholesterol already in the blood. This process lowers overall cholesterol levels as well as the risk of heart disease and heart attacks.

One problematic and newly discovered side effect of Lipitor is the increased potential for developing Type 2 diabetes. Just last year the FDA mandated a change to Lipitor’s warning label. The new label specifically tells users of the threat of diabetes. Other statins, like Zocor and Crestor, were also required to make similar label changes.

Pfizer and Endo Pharmaceuticals reached a settlement with the State of Texas to pay $50 million to settle a lawsuit accusing these drug companies of falsifying drug prices to bleed Texas’ Medicaid program.

As often happens, the case stemmed from a whistleblower lawsuit, this one by Ven-A-Care who has a history of filing these claims against pharmaceutical companies.

Ven-A-Care is basically four guys who have become professional witness blowers that have made hundreds of millions of dollars for their companies. These guys lay low: they don’t talk to the media and have not spoken publicly since 2004.

On Monday, the 2nd Circuit ruled that the plaintiff in the Zyprexa lawsuit knew (or should have known) that Zyprexa potentially caused his diabetes more than two years before he sued Eli Lily.

Plaintiff was told by his doctor that he had diabetes in the late 1980’s or early 1990’s. He was prescribed Zyprexa in 1997 and continued taking it until late 2001, when his doctor took him off took him off of the drug due to weight gain.

Plaintiff’s lawsuit (filed in 2006) claimed that while taking the drug, his glycemic control significantly worsened and that towards the end, he developed diabetes-related complications.

The U.S. Supreme Court yesterday shot down a petition by a Johnson & Johnson to hear a case in which J&J sought a ruling that preemption should be extended to failure to warn claims involving over-the-counter drugs.

Drug and medical device defendants continue to think preemption is some magic elixir around their negligence.

Hey, you Republicans out there. Does it bother you that state tort rights are being tossed in the ground by the overly intrusive federal government? If you answered yes, you are a real Republican. I have a Barry Goldwater sticker for you. The rest of you are just Republicans when it is convenient for you.

Plaintiff’s only expert on causation in a Zometa jaw injury case was excluded last week when an Alabama court determined that an oral surgeon was unqualified to offer a causation opinion.

If you are not familiar with these cases, Plaintiff’s lawsuit reads like many of these tragic cases. Plaintiff alleges she developed Avascular osteonecrosis of the jaw as a result of taking Zometa for post-cancer treatment of bone loss or osteoporosis. That’s the worst, right? You slay the beast that is cancer only to get another awful condition, arguably from the drug that was supposed to help you.

Plaintiff’s lawyers designated her treating oral surgeon as plaintiff’s only expert on the issue of specific causation. Right off the bat, this sounds dangerous. Unless the treating surgeon just happens to have the experience and expertise to speak to this issue, you are risking having an expert that lacks credibility with the jury or, worse, is not permitted to testify. Plaintiff’s lawyer later tried to add more experts after the deadline, but the court shot that effort down.

In January, Johnson & Johnson got a defense verdict in a Levaquin case involving Achilles tendon injuries to a 78-year-old man who alleged that Levaquin did not carry an appropriate warning of the risks of such an injury.

This was the third bellwether trial in the MDL. This win upped J&J’s record in the Levaquin cases to 2-1. J&J lost the first Levaquin lawsuit in December 2010 when a jury awarded $1.8 million in compensation to a Minnesota man. A year ago, it won a defense verdict in state court in New Jersey.

There are always lots of potential appellate issues for both sides in these complex cases. Plaintiff moved for a new trial, contending that the jury’s verdict was against the weight of evidence. Okay, that one pretty much always fails. But the plaintiff also alleged that the trial judge mistakenly failed to exclude a juror who found out in the middle of the trial that their company did some work for J&J.

A Maryland federal judge last week put some tough limitations on plaintiffs’ expert in the Aredia/Zometa jaw injury case that was remanded back to Maryland from the MDL.

In Zimmerman v. Novartis Pharmaceuticals, plaintiffs brought a wrongful death lawsuit in the MDL. Plaintiff asserted strict liability and negligence claims against Novartis. Plaintiff was prescribed Aredia and Zometa, two bisphosphonate drugs that are administered intravenously to treat cancer patients for hypercalcemia, a potentially fatal elevation of calcium in the blood. Plaintiff developed osteonecrosis of the jaw which caused her death.

The case sat for years in the MDL in Tennessee, but has since been remanded to Maryland to be tried before Judge Roger W. Titus. Novartis sought to exclude the testimony of a key plaintiff’s expert. The expert, a doctor, is a key witness for plaintiff because she was, at one time, a medical officer with the FDA in the Office of Health Affairs. Defendants use the tacit backing of the FDA at every trial – WE WERE FDA APPROVED! – is a common theme banged over the heads of the juries. So having a doctor who worked for the FDA sometimes helps plaintiffs considerably.